Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07584954

Phase I, Open-labeled, Dose-escalation, Dose-expansion Study Evaluating the Safety, Tolerance, Pharmacokinetics, and Activity of IUAb190708 in Patients With Advanced or Recurrent Solid Tumors

Led by Jun Zhou · Updated on 2026-05-13

90

Participants Needed

6

Research Sites

210 weeks

Total Duration

On this page

Sponsors

J

Jun Zhou

Lead Sponsor

F

Fudan University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is to evaluate a novel cytotoxic anti-PD-L1, IUAb190708, for the treatment of tumor

CONDITIONS

Official Title

Phase I, Open-labeled, Dose-escalation, Dose-expansion Study Evaluating the Safety, Tolerance, Pharmacokinetics, and Activity of IUAb190708 in Patients With Advanced or Recurrent Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult males or females aged 18 to 75 who understand and voluntarily sign informed consent
  • Diagnosed with metastatic or locally advanced solid tumors with no effective treatment available or unsuitable/refusing standard treatment
  • Positive PD-L1 expression required for certain tumors depending on study phase
  • Able to provide fresh or archived tissue samples
  • At least one measurable tumor lesion per iRECIST criteria
  • Life expectancy of 3 months or more
  • ECOG Performance Status of 0 to 1
  • Adequate organ function with no recent blood transfusions, erythropoietin, or granulocyte colony-stimulating factor within 14 days
  • Women of child-bearing potential must have a negative pregnancy test and agree to use effective contraception; male partners must also agree to use contraception from consent until 6 months after last dose
Not Eligible

You will not qualify if you...

  • Serious or active infection requiring intravenous antibiotics within 4 weeks before first dose
  • Recent use of nitrosourea, mitomycin C, oral fluorouracil derivatives, small molecule targeted drugs, endocrine therapy, immunotherapy, traditional Chinese medicine, chemotherapy, radiation, or biotherapy within specified time frames before first dose
  • Other primary active malignant tumors within 5 years prior to first dose
  • Significant cardiovascular diseases
  • Untreated or unstable primary CNS tumors or CNS metastases requiring steroids or other treatments
  • Allergy or hypersensitivity to study drug or excipients
  • History of allogeneic organ transplant
  • HIV or other immunodeficiency infections
  • Serious psychiatric or medical conditions interfering with adherence
  • Systemic corticosteroid or immunosuppressive therapy within 2 weeks before first dose, except certain topical or short-term uses
  • Active autoimmune diseases requiring systemic treatment within 2 years, except stable type I diabetes or autoimmune hypothyroidism
  • History of certain lung diseases or active pneumonia
  • Previous severe immune-related adverse events from immunotherapy
  • Unresolved adverse effects from previous cancer treatments
  • Major surgery within 4 weeks before first dose or planned surgery during study participation
  • Positive for certain infections such as syphilis or active hepatitis B or C
  • Other clinical or laboratory conditions deemed unsuitable by investigator
  • Pregnant or breastfeeding women
  • History of serious systemic diseases deemed unsuitable by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Fujian Cancer Hospital

Fuzhou, Fujian, China

Actively Recruiting

2

Anyang tumor hospital

Anyang, Henan, China

Actively Recruiting

3

Cancer hospital of Shandong First Medical University

Jinan, Shandong, China

Actively Recruiting

4

Fudan University Shanghai cancer center

Shanghai, China

Actively Recruiting

5

Shanghai Pulmonary hospital

Shanghai, China

Actively Recruiting

6

Shanghai Xinhua hospital

Shanghai, China

Actively Recruiting

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Research Team

J

Jun Zhou, Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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